New Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome
Launched by WALTER REED NATIONAL MILITARY MEDICAL CENTER · Jan 2, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for Bladder Pain Syndrome (BPS) in women aged 18 and older. BPS can cause significant discomfort, and while there are various treatments available, not all work for everyone. The trial is investigating whether using a small amount of electrical energy aimed at a specific group of nerves in the lower abdomen can help reduce pain associated with BPS. Some participants will receive this treatment, while others will receive a placebo, which means they won't be receiving the actual treatment but will be part of the study for comparison purposes.
To be eligible to participate, women must have a confirmed diagnosis of BPS and meet certain health criteria. If you join the study, you'll have an initial appointment to assess your symptoms, followed by a procedure where two tiny needles are placed in your back to deliver the electrical treatment. This procedure is quick and is only done once. Afterward, you’ll check in with the research team at one, three, and six months to talk about your pain levels, mood, and other related symptoms. The goal is to find out if the new treatment helps improve symptoms better than the placebo. Participating in this study could potentially provide you with relief from BPS symptoms and contribute to advancing research on this condition.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female sex
- • Age greater than or equal to 18
- • Diagnosis of Bladder Pain Syndrome as evidenced by score greater than or equal to six on O'Leary-Sant Voiding and Pain Indices
- • DEERS-eligible health care beneficiaries
- Exclusion Criteria:
- • Patients with current enabled implantable neurostimulation (i.e. transcutaneous electrical nerve stimulation unit, Interstim)
- • Current active pelvic or gynecologic malignancy
- • Coagulation disorder
- • Local infection at injection site
- • Sepsis
- • Decompensated cardiac or hemodynamic disorders
- • Neurogenic bladder and patients with spinal cord injury
- • Current pregnancy
- • Structural abnormalities of the spine that prevent performance of the procedure
- • Intravesical onabotulinumtoxin A injection within the last 3 months
About Walter Reed National Military Medical Center
Walter Reed National Military Medical Center (WRNMMC) is a premier medical facility dedicated to providing comprehensive healthcare services to military personnel, their families, and veterans. As a leader in clinical research and trials, WRNMMC focuses on advancing medical knowledge and improving patient outcomes through innovative studies in various fields, including trauma care, infectious diseases, and rehabilitation. The center is committed to upholding the highest ethical standards in research while fostering collaboration among military and civilian healthcare professionals. Its mission is to enhance the health and well-being of service members and the broader community through cutting-edge research and evidence-based practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Patients applied
Trial Officials
Eli Medvescek, MD
Principal Investigator
Walter Reed National Military Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported